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This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary incontinence-in patients with resistant hypertension. The intervention aims to improve treatment adherence and blood pressure control. The primary outcome is a reduction of ≥10 mmHg in systolic blood pressure, measured by ambulatory blood pressure monitoring (ABPM) before and after the intervention during routine and study-specific visits. The study targets adult patients on three or more antihypertensive medications who experience or are at risk of drug-related side effects. This educational approach is expected to enhance patient understanding, reduce treatment discontinuation, and improve clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational intervention on the adverse effects of antihypertensive medication | Experimental | Patients in this group will receive a nurse-led educational program focused on the adverse effects of antihypertensive medications, particularly sexual dysfunction and urinary incontinence. The intervention aims to provide patients with tools and strategies to manage these side effects, improve their understanding of antihypertensive drugs, and enhance their adherence to prescribed treatments. The intervention will include:
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| Standard Care | Active Comparator | Patients in this group will receive standard care as prescribed by their nurse, without the added educational component focused on the adverse effects of antihypertensives. This group will continue their usual treatment regimen for resistant hypertension, which may include medication adjustments and general counselling by nurse as part of their routine visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention for Adverse Drug Effects | Behavioral | Patients will receive from 6 to 9 educational sessions, each lasting approximately 30-45 minutes. The sessions will occur over a period of 6 months, with follow-up as necessary during study visits.The intervention will include:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) from Baseline to Post-Intervention | The primary outcome of this study is the change in systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) before (baseline) and after the educational intervention (post-intervention). A reduction of at least 10 mmHg in systolic blood pressure is considered a significant clinical improvement. This outcome will be measured during both routine clinical visits and study-specific visits to assess the effectiveness of the nurse-led educational intervention in improving blood pressure control. | Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Blood Pressure (DBP) from Baseline to Post-Intervention | The change in diastolic blood pressure (DBP) from baseline to post-intervention will also be assessed using ambulatory blood pressure monitoring (ABPM) to evaluate the overall effect of the educational intervention on blood pressure control. | Baseline measurement (pre-intervention) at the start of the study visit, and Post-intervention measurement after 6 months of the educational program |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complex Hospitalari Universitari Moisès Broggi, Consorci Sanitari Integral | Sant Joan Despà | Barcelona | E-08970 | Spain |
Results will be published, but individual participant data will not be shared.
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| routine care | Other | Patients will receive standard care as prescribed by their nurse. This group will continue their usual treatment regimen for resistant hypertension, which may include medication adjustments and general counselling by nurse as part of their routine visits. |
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| Medication Adherence Rate | Adherence to antihypertensive medications will be assessed using a 8-item Morisky test during the study visits. The goal is to assess whether the educational intervention improves medication adherence by addressing side effects, enhancing patient knowledge, and motivating consistent therapy adherence. | Adherence will be measured at baseline and post-intervention (at 6 months). |
| sexual dysfunction | Standardized questionnaires related to sexual health (for example, Sexual Health Inventory for Men (SHIM) | At baseline and 6 months after the intervention. |
| urinary incontinence | Standardized questionnaires will be applied to assess and urinary incontinence (for example, Incontinence Quality of Life (I-QOL)). | At baseline and 6 months after the intervention. |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D012735 | Sexual Dysfunction, Physiological |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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